1. Field of the Invention
The present invention relates generally to surgical drapes and more particularly to a surgical drape for a limb upon which surgery is to be performed.
2. Description of the Prior Art
In the past, it has been a standard procedure to drape extremities utilizing a number of individual, singularly folded, linen sheets to provide a sterile field to cover the entire patient, yet leave the extremity accessible and free to be manipulated into the desired position. This has been formerly accomplished by allowing one nurse (unsterile) to elevate the limb while the surgeon and one or more assistants, all of whom are sterile, position the drapes under and over the extremity, the torso, etc. During this procedure, the sterile surgical team comes in close contact with the (unsterile) nurse out of necessity, and therefore is risk, knowingly or unknowingly, of contamination. A sterile, rolled, knit stocking may be placed over the distal end of the extremity and unrolled to cover the limb and provide a sterile cover for the surgeon to safely manipulate. During the unrolling of the stocking, a sterile hand not uncommonly may come in contact with an unsterile area, again thereby, either knowingly or unknowingly, contaminating the operative field.
The covered limb is then laid on the sterile bottom drapes and more sheets, usually five to seven in number, are introduced to cover the area above the extremity. The bottom sheets are then attached to the top sheets by means of sterile "towel clips." At this point, another possible source of contamination is introduced in that the points of the "towel clips" pass through the sterile outer edges of the drapes and may come into contact with the contaminated underside. It is not unusual during the course of a surgical procedure for a "towel clip" to pop open and fall onto the sterile field, again contributing to general contamination.
The above factors outlining frequent causes of contamination, combined with the time-consuming procedure of placing multiple sheets and sometimes followed by rolling the stocking over the limb and clipping the sheet edges together, impose a constant threat to the patient, with loss of aseptic conditions and increased anesthesia hazard by prolongation, thereby rendering currents standards of contemporary draping systems entirely inefficient and undesirable.
The reusable linen draping system poses additional undesirable factors which are subjected to the problems of quality control including imperfect laundering, hand folding, steam sterilization (which may introduce unknown contamination due to the drape packs being stored while still damp), undetected holes and tears, storage problems due to bulky packaging and possible contamination during transportation between laundry and surgical sites.
The prior art has generally been directed to covering extremities (such as legs) so as to isolate a surgical area other than the limb, from the limb itself. A typical surgical legging drape is illustrated in U.S. Pat. No. 3,777,749 wherein the leg is to be draped as an unprepared area to prevent contamination of the surgical site by the unprepared leg. For obstetrical or gynocological operative procedures, prior art devices have included a drape having separate leggings, as illustrated in U.S. Pat. No. 3,039,957, or separate leg drapes as in U.S. Pat. No. 3,693,618. In all of these patents, the object or area of surgery is other than the extremity which is draped. Similarly, these prior art systems are rather complicated, involving a multitude of elements interrelated such that their application to the patient is cumbersome, time-consuming and susceptible to undesirable contamination.
The most simple surgical drape available on the market provides a single sheet of drapable material having an enlarged aperture covered with a second material which is cut by the surgeon to provide a fenestration through which is passed the limb to be operated on. This drape is used with a second drape for the limb to provide a completely draped system. It should be noted that this system, though involving a reduced number of drapes, still involves the judgment and skill of the surgeon or assistant nurse to cut the fenestration in the second material so as to minimize the exposure of the patent's body under the drape area. Even with an accurately cut fenestration, a perfect fit with the limb cannot be achieved.
Thus, there exists a need for a draping system which isolates the surgical area of an extremity from the rest of the patient's body, which at the same time is convenient to use and not susceptible to high degrees of contamination.